WO2022030170A1 - Tube pour canal lacrymal - Google Patents

Tube pour canal lacrymal Download PDF

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Publication number
WO2022030170A1
WO2022030170A1 PCT/JP2021/025675 JP2021025675W WO2022030170A1 WO 2022030170 A1 WO2022030170 A1 WO 2022030170A1 JP 2021025675 W JP2021025675 W JP 2021025675W WO 2022030170 A1 WO2022030170 A1 WO 2022030170A1
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WO
WIPO (PCT)
Prior art keywords
tube
lacrimal
lacrimal duct
tube member
endoscope
Prior art date
Application number
PCT/JP2021/025675
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English (en)
Japanese (ja)
Inventor
克也 宮川
美沙 松本
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Priority to JP2022541168A priority Critical patent/JPWO2022030170A1/ja
Publication of WO2022030170A1 publication Critical patent/WO2022030170A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • This disclosure relates to the lacrimal duct tube.
  • a treatment for lacrimal duct obstruction for example, surgery based on sheath-guided endoscopic puncture (SEP) is performed.
  • SEP sheath-guided endoscopic puncture
  • an endoscope is inserted into a sheath made of a flexible cylindrical body such as silicon, and the obstruction site is pressed with the tip of the sheath while checking the lacrimal passage to open the lacrimal passage. .. Then, only the endoscope is pulled out while leaving the sheath in the lacrimal passage, and the lacrimal duct tube is inserted into the sheath left in the lacrimal passage using a metal rod called a bougie.
  • the lacrimal duct tube passes through the sheath and inserted to the position where it is to be indwelled, by pulling out the bougie and the sheath, only the lacrimal duct tube is indwelled in the lacrimal duct.
  • the lacrimal duct tube is removed after being indwelled for about 1 month, and the treatment for lacrimal duct obstruction is completed.
  • a lacrimal duct tube used for this treatment for example, a lacrimal duct tube characterized by being excellent in insertability into a sheath and being difficult to be removed from the sheath is known (see Patent Document 1).
  • the sheath is used to eliminate the obstruction of the lacrimal passage and to place the lacrimal duct tube.
  • a step of inserting into the canal, a step of pulling the endoscope out of the sheath, a step of inserting a lacrimal duct tube into the sheath left in the lacrimal passage, and a step of pulling out the sheath from the lacrimal passage are required. Therefore, there is a problem that an operation error may occur due to the complicated procedure and an increase in the treatment process, and the treatment time becomes long.
  • the object of the present disclosure is that the endoscope can be inserted directly into the lacrimal duct tube, and the obstruction site can be opened and placed in the lacrimal duct without using a sheath when treating lacrimal duct obstruction. It is to provide a lacrimal duct tube.
  • One aspect of the lacrimal duct tube of the present disclosure comprises an opening at the tip, an insertion hole for inserting an endoscope on the proximal end side, a tube member to be placed in the lacrimal passage, and the tube member is a wire rod. It has a reinforcing portion, and the wire rod reinforcing portion has an inner layer, an outer layer, and a reinforcing layer provided between the inner layer and the outer layer.
  • the tube member is reinforced by the wire rod reinforcing portion. It is possible to realize a lacrimal duct tube with sufficient strength and flexibility. Further, since a large inner diameter of the tube member can be secured, the endoscope can be directly inserted into the tube member and the obstructed portion can be opened while checking the lacrimal passage. In addition, because it has sufficient strength and flexibility, the tube member can be operated to open the obstructed part, and tears that are not easily crushed even when placed in the lacrimal passage and are not easily damaged when an endoscope is inserted. Can be a road tube.
  • the tube member may have a transparent tip portion on the tip side of the wire rod reinforcing portion.
  • the outer layer may be treated with hydrophilicity.
  • the tube member may have a proximal end portion having an insertion hole on the proximal end side of the wire rod reinforcing portion.
  • the reinforcing layer may be formed of a metal blade material. With such a configuration, the strength of the tube member can be easily secured.
  • the thickness of the wire rod reinforcing portion may be 0.2 mm to 0.5 mm.
  • the number of tube members is two, and a connecting portion for connecting the base ends of the two tube members may be further provided.
  • one of the two tube members can be inserted into the upper lacrimal canaliculi and the other into the lower canaliculi, and the two tube members are connected so that they are placed in the lacrimal canaliculus. It is possible to prevent the canaliculi tube from coming off.
  • the indwelling lacrimal duct tube can be easily taken out.
  • the object of the present disclosure is that the endoscope can be inserted directly into the lacrimal duct tube, and the obstruction site can be opened and placed in the lacrimal duct without using a sheath when treating lacrimal duct obstruction. It is to provide a lacrimal duct tube.
  • FIG. 1 is a perspective view of a lacrimal duct tube according to an embodiment.
  • FIG. 2 is a cross-sectional view taken along the line II-II of FIG.
  • FIG. 3 is a cross-sectional view taken along the line III-III of FIG.
  • FIG. 4A is a schematic view showing a treatment process for lacrimal duct obstruction using a lacrimal duct tube according to an embodiment.
  • FIG. 4B is a schematic view showing a treatment process for lacrimal duct obstruction using a lacrimal duct tube according to an embodiment.
  • FIG. 4C is a schematic view showing a treatment process for lacrimal duct obstruction using a lacrimal duct tube according to an embodiment.
  • the lacrimal duct tube 1 of the present disclosure has two tube members 2 and 2, and the base ends of the tube members 2 and 2 are connected to each other by a connecting portion 3. ..
  • the tube member 2 has a wire rod reinforcing portion 5, a tip portion 4 is provided on the tip end side of the wire rod reinforcing portion 5, and a proximal end portion 6 is provided on the proximal end side.
  • the wire rod reinforcing portion 5 is formed by laminating an inner layer 5a, an outer layer 5c, and a reinforcing layer 5b provided between the inner layer 5a and the outer layer 5c.
  • the inner layer 5a is located inside the wire rod reinforcing portion 5 and forms the lumen 7 of the tube member 2.
  • the constituent material of the inner layer 5a is, for example, a fluoroplastic resin, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy alkane resin (PFA), and the like, and polytetra is preferable. It is fluoroethylene (PTFE). Since a fluorine-based thermoplastic resin such as polytetrafluoroethylene has low friction, by forming the inner layer 5a with the fluorine-based thermoplastic resin, the endoscope 20 in the wire rod reinforcing portion 5 (see FIG. 4A and the like).
  • the slipperiness is improved and the operability can be improved.
  • dirt does not easily adhere to the inner layer 5a, and body fluids such as tears easily flow, so that it is possible to prevent the lumen 7 from being clogged.
  • the fluorine-based thermoplastic resin has excellent heat resistance, it is easy to mold the wire rod reinforcing portion 5 having a laminated structure.
  • the reinforcing layer 5b is provided so as to cover the outer periphery of the inner layer 5a, and reinforces the wire rod reinforcing portion 5.
  • the reinforcing layer 5b is formed of a braid material formed by knitting a plurality of wire rods or the like (not shown).
  • the constituent material of the wire rod is, for example, metal or resin, and examples of the metal include stainless steel.
  • the constituent material of the wire is preferably stainless steel. Since stainless steel has high strength and excellent heat resistance, it is easy to mold the reinforcing layer 5b.
  • the reinforcing layer 5b may not be woven as long as it is constructed by using a wire rod, or may be formed by winding the wire rod in a coil shape.
  • the outer layer 5c is provided so as to cover the outer periphery of the reinforcing layer 5b, and forms the outer peripheral surface of the wire rod reinforcing portion 5.
  • the constituent material of the outer layer 5c is, for example, a thermoplastic synthetic resin, polyurethane (PU), polyether blockamide (PEBA), polyethylene (PE), polypropylene (PP), polyamide (PA), polyimide (PI), polyamide. Examples thereof include imide (PAI) and polyethylene terephthalate (PET), and polyurethane (PU) is preferable.
  • the lacrimal passage 18 is not easily damaged and the hydrophilic treatment is easily applied.
  • the outer peripheral surface of the outer layer 5c is subjected to the hydrophilic treatment, it can be carried out with hyaluronic acid, polyvinylpyrrolidone, polyvinyl alcohol (PVA) or the like.
  • PVA polyvinyl alcohol
  • the friction between the lacrimal passage 18 and the lacrimal duct tube 1 is reduced, so that the lacrimal duct tube 1 becomes slippery in the lacrimal duct 18 and the operability is improved.
  • the lacrimal duct tube 1 can be easily inserted and removed, and the burden on the patient can be reduced.
  • the outer layer 5c may be one layer, but may be two or more layers.
  • each layer may be made of the same material having different hardness.
  • polyurethane having different hardness can be used between the inside of the outer layer 5c (the side of the reinforcing layer 5b) and the outside of the outer layer 5c (the outer peripheral side of the wire rod reinforcing portion 5).
  • the inner diameter of the wire rod reinforcing portion 5 is preferably 0.9 mm or more, 1.1 mm or less, and more preferably 1.0 mm.
  • the outer diameter of the wire rod reinforcing portion 5 is preferably 1.2 mm or more, 1.5 mm or less, and more preferably 1.2 mm.
  • the thickness of the wire rod reinforcing portion 5 is preferably 0.2 mm or more, 0.5 mm or less, and more preferably 0.2 mm.
  • the wire rod reinforcing portion 5 into a three-layer structure having the reinforcing layer 5b, it can be formed thin while maintaining the strength of the tube member 2, and a lumen 7 into which the endoscope 20 can be inserted is secured. can.
  • the reinforcing layer 5b is formed by knitting a wire rod, the operability of the tube member 2 is not impaired, and the strength and flexibility can be ensured.
  • the tip of the tip 4 of the tube member 2 is provided with an opening 8 that communicates with the lumen 7 of the tube member 2.
  • the tip portion 4 is made of, for example, polyurethane (PU) and is transparent. By making the tip portion 4 transparent so that visible light can pass through, when the endoscope 20 is inserted up to the vicinity of the tip portion 4, the lacrimal passage 18 can be confirmed from the side surface of the tip portion 4 in addition to the opening 8. Therefore, a wide field of view of the endoscope 20 can be secured. Further, since the endoscope 20 can be operated while confirming the lacrimal passage 18 over a wider area, the operability of the lacrimal duct tube 1 can be improved.
  • PU polyurethane
  • the tip portion 4 can be formed in a tapered shape in which the inner diameter gradually decreases from the base end side connected to the wire rod reinforcing portion 5 to the tip end side where the opening 8 is provided.
  • the outer peripheral surface of the tip portion 4 can be subjected to hydrophilic treatment such as hyaluronic acid, polyvinylpyrrolidone, and polyvinyl alcohol (PVA).
  • the lacrimal duct tube 1 of the present disclosure is provided with a tip portion 4 at the tip of the tube member 2, but the tip portion 4 has an arbitrary configuration, and even if the tip portion 4 is not provided, endoscopy is performed from the opening 8. It is possible to secure the field of view of the mirror 20 and confirm the lacrimal passage 18. Further, although the case where the tip portion 4 is a single layer is exemplified, it may be a multilayer structure made of the same or different materials.
  • the base end portion 6 of the tube member 2 is provided with an insertion hole 9 for inserting the endoscope 20.
  • the insertion hole 9 can be easily formed by providing the base end portion 6 without the reinforcing layer 5b on the base end side of the wire rod reinforcing portion 5 and providing the insertion hole 9 in the base end portion 6.
  • the insertion hole 9 can be provided on the side surface of the proximal end portion 6 or on the end surface on the proximal end side of the proximal end portion 6.
  • the shape of the insertion hole 9 is an elliptical shape extending in the circumferential direction of the tube member 2, but the shape is not limited as long as the endoscope 20 can be inserted, and may be, for example, a circular shape or a rectangular shape. By making the insertion hole 9 an elliptical shape, it is less likely to be damaged even if the periphery of the insertion hole 9 is pulled by an operation of the endoscope 20 or the like.
  • the size of the insertion hole 9 is not particularly limited as long as the endoscope 20 can be inserted, but can be, for example, 0.9 mm or more. Further, by coloring the outer periphery of the insertion hole 9, the position of the insertion hole 9 can be easily recognized, and operations such as inserting the endoscope 20 can be easily performed.
  • the base end portion 6 is formed so as to gradually become thinner from the position on the base end side of the insertion hole 9 to the base end of the base end portion 6 connected to the connection portion 3. Since the endoscope 20 is inserted from the insertion hole 9 toward the tip end side of the tube member 2, it is not inserted from the insertion hole 9 to the proximal end side, but from the insertion hole 9 of the proximal end portion 6 to the proximal end side. It can be formed finely.
  • the base end portion 6 is made of, for example, polyurethane (PU) or the like, and the outer peripheral surface thereof can be subjected to a hydrophilic treatment such as hyaluronic acid, polyvinylpyrrolidone, polyvinyl alcohol (PVA). Although the case where the base end portion 6 is a single layer is exemplified, the base end portion 6 may have a multi-layer structure made of the same or different materials.
  • the tip portion 4 and the wire rod reinforcing portion 5 are connected by welding the base end side of the tip portion 4 and the outer layer 5c on the tip end side of the wire rod reinforcing portion 5. Further, in the tube member 2, the wire rod reinforcing portion 5 and the proximal end portion 6 are connected by welding the outer layer 5c on the proximal end side of the wire rod reinforcing portion 5 and the distal end side of the proximal end portion 6.
  • the tip portion 4, the wire rod reinforcing portion 5, and the base end portion 6 constituting the tube member 2 are integrally communicated with each other by being welded, and from the viewpoint of facilitating welding, the tip portion 4, It is preferable that the outer layer 5c and the base end portion 6 of the wire rod reinforcing portion 5 are formed of the same material.
  • the connecting portion 3 connecting the two tube members 2 and 2 connects the proximal ends of the proximal end portions 6 and 6 to each other.
  • the connecting portion 3 connecting the two tube members 2 and 2 connects the proximal ends of the proximal end portions 6 and 6 to each other.
  • the lacrimal duct tube 1 is less likely to come off when the lacrimal duct tube 1 is placed in the lacrimal duct 18.
  • the tear duct tube 1 can be easily taken out by pulling it out by holding the connecting portion 3.
  • the connecting portion 3 may be formed as long as the base ends of the two tube members 2 and 2 can be connected to each other, and the connecting portion 3 may be integrally formed with the two tube members 2 and 2.
  • the shape of the connection portion 3 may be a hollow tube shape or a solid string shape.
  • the lumen of the connecting portion 3 is formed to be, for example, 0.7 mm or less.
  • connection portion 3 can be reduced and can be made inconspicuous from the outside. Further, body fluids such as tears pass through the connection portion 3, pass through the lumen 7 of the tube member 2 and the gap between the tube member 2 and the lacrimal passage 18, and are discharged from the nose. Therefore, by forming the connecting portion 3 thinly, the effect becomes higher and tears and the like are easily discharged.
  • a mark 10 is attached to the center of the connection portion 3 in the longitudinal direction, and the mark 10 can be used as a mark when the lacrimal duct tube 1 is placed.
  • the lacrimal duct tube 1 of the present disclosure has a mark 10 at the center of the connection portion 3, it may or may not be attached at any position other than the center.
  • connection portion 3 examples include polyurethane (PU).
  • PU polyurethane
  • the connecting portion 3 and the base end portion 6 are preferably formed of the same material, which facilitates welding.
  • the length from the opening 8 of one tube member 2 to the opening 8 of the other tube member 2 is preferably 90 mm or more and 120 mm or less. , More preferably 105 mm.
  • the length of the tube member 2 is generally about 40 mm from the lacrimal punctum to the nasolacrimal duct, and is preferably 30 mm or more and 40 mm or less, more preferably 40 mm or less, from the viewpoint of placement in the lacrimal duct 18. It is 40 mm.
  • the length of the wire rod reinforcing portion 5 is preferably 20 mm or more, 38 mm or less, and more preferably 28 mm from the viewpoint of ensuring the strength of the tube member 2.
  • the length of the wire rod reinforcing portion 5 can be preferably 50% or more, more preferably 70% of the length of the tube member 2.
  • the length of the tip portion 4 is preferably 1 mm or more and 3 mm or less, and more preferably 2 mm from the viewpoint of securing the field of view of the endoscope 20.
  • the length of the connecting portion 3 is preferably 20 mm or more, 30 mm or less, and more preferably 25 mm from the viewpoint of operability of the lacrimal duct tube 1.
  • the lacrimal passage tube 1 is a lacrimal passage composed of one tube member 2 in which two tube members 2 and 2 are connected by a connecting portion 3 but not connected by the connecting portion 3. Tube 1 can also be used to treat lacrimal duct obstruction.
  • FIG. 4A shows a state in which the lacrimal duct tube 1 into which the endoscope 20 is inserted is inserted into the lacrimal duct 18.
  • FIG. 4B shows a state in which the obstruction site 19 is pressed by the lacrimal duct tube 1.
  • FIG. 4C shows a state in which the lacrimal duct tube 1 is placed in the lacrimal duct 18.
  • the lacrimal passage 18 includes an upper punctum 11, a lower punctum 12, an upper canaliculi 13, a lower canaliculi 14, a total canaliculi 15, a lacrimal sac 16, and a nasal canaliculi 17.
  • the endoscope 20 is inserted into the tube member 2 through the insertion hole 9 of one of the tube members 2, and the tip portion of the endoscope 20 is moved to the transparently formed tip portion 4, and the field of view of the endoscope 20 is reached.
  • the tube member 2 and the endoscope 20 are inserted from the upper tear point 11 and the lacrimal passage 18 is confirmed by the endoscope 20. Is inserted from the upper canaliculi 13 into the total canaliculi 15, the lacrimal sac 16, and the nasolacrimal duct 17.
  • FIG. 4A With the endoscope 20 inserted in the tube member 2, the tube member 2 and the endoscope 20 are inserted from the upper tear point 11 and the lacrimal passage 18 is confirmed by the endoscope 20. Is inserted from the upper canaliculi 13 into the total canaliculi 15, the lacrimal sac 16, and the nasolacrimal duct 17. As shown in FIG.
  • the endoscope 20 is inserted into the tube member 2 from the insertion hole 9 of the other tube member 2, and the tip portion of the endoscope 20 is moved to the transparently formed tip portion 4.
  • the tube member 2 With the endoscope 20 inserted in the tube member 2, the tube member 2 extends from the lower punctum 12 where the tube member 2 is not placed to the lower canaliculi 14, the total canaliculi 15, the lacrimal sac 16, and the nasolacrimal duct 17. And the endoscope 20 is inserted. After that, when the obstruction site 19 is found, the tube member 2 is inserted into the inner part of the lacrimal passage 18 while pressing with the tip of the tip portion 4 to open the obstruction site 19.
  • the endoscope 20 is pulled out from the insertion hole 9 while leaving the tube member 2 in the lacrimal passage 18.
  • the other tube member 2 is placed in the lacrimal punctum 18.
  • the position of the mark 10 attached to the center of the connection portion 3 can be referred to, and the connection portion 3 can be adjusted so as to be located at the inner corner of the eye.
  • one tube member 2 is inserted from the upper punctum 11, but first one of the tube members 2 is inserted from the lower punctum 12, and then the other is inserted from the upper punctum 11.
  • the lacrimal punctum tube 1 may be placed in the lacrimal punctum 18.
  • the tube member 2 is formed thinly to secure a large inner diameter while keeping the outer diameter of the tube member 2 small, so that the endoscope is directly attached to the tube member 2. 20 can be inserted and the obstruction site 19 can be opened while confirming the lacrimal passage 18. Further, since the tube member 2 is reinforced by the wire rod reinforcing portion 5, the tube member 2 can secure strength while maintaining flexibility and operability. Therefore, the tube member 2 can be operated to open the obstructed portion 19, and even if the lacrimal duct tube 1 is placed in the lacrimal duct 18, it is difficult to be crushed.
  • the obstruction site 19 is opened and the lacrimal duct tube 1 is teared without using a sheath. Can be detained on road 18.
  • the treatment step related to the sheath becomes unnecessary, and the number of treatment steps can be reduced as compared with the conventional case, so that it is possible to reduce the occurrence of operation errors.
  • the treatment time becomes shorter, and the burden on doctors and patients can be reduced.
  • the lacrimal duct tube of the present disclosure allows the endoscope to be inserted directly into the lacrimal duct tube, allowing the occlusion site to be opened and placed in the lacrimal duct without using a sheath when treating lacrimal duct obstruction. Useful as a possible lacrimal duct tube.

Abstract

Tube pour canal lacrymal (1) qui comprend un élément de tube (2) devant être implanté dans un canal lacrymal (18) et comporte une ouverture (8) au niveau d'une extrémité de pointe et un trou d'insertion (9) pour insérer un endoscope (20) sur un côté d'extrémité de base. L'élément de tube (2) présente une partie de renforcement de fil (5). La partie de renforcement de fil (5) a une couche interne (5a), une couche externe (5c), et une couche de renforcement (5b) qui est disposée entre la couche interne (5a) et la couche externe (5c). Lorsqu'une occlusion lacrymale doit être traitée, l'endoscope (20) est inséré directement dans le tube pour canal lacrymal (1), ce qui permet d'ouvrir la zone occluse (19) et d'implanter le tube pour canal lacrymal (1) dans le canal lacrymal (18) sans utiliser de gaine.
PCT/JP2021/025675 2020-08-05 2021-07-07 Tube pour canal lacrymal WO2022030170A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022541168A JPWO2022030170A1 (fr) 2020-08-05 2021-07-07

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020133035 2020-08-05
JP2020-133035 2020-08-05

Publications (1)

Publication Number Publication Date
WO2022030170A1 true WO2022030170A1 (fr) 2022-02-10

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ID=80119765

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Application Number Title Priority Date Filing Date
PCT/JP2021/025675 WO2022030170A1 (fr) 2020-08-05 2021-07-07 Tube pour canal lacrymal

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JP (1) JPWO2022030170A1 (fr)
WO (1) WO2022030170A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014034367A1 (fr) * 2012-08-31 2014-03-06 株式会社カネカ Tube pour conduit lacrymal
WO2014115700A1 (fr) * 2013-01-24 2014-07-31 株式会社カネカ Tube pour voies lacrymales
WO2015111553A1 (fr) * 2014-01-22 2015-07-30 株式会社カネカ Tube lacrymal
US20190336339A1 (en) * 2016-01-27 2019-11-07 Sinopsys Surgical, Inc. Paranasal sinus access implant devices and related products and methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014034367A1 (fr) * 2012-08-31 2014-03-06 株式会社カネカ Tube pour conduit lacrymal
WO2014115700A1 (fr) * 2013-01-24 2014-07-31 株式会社カネカ Tube pour voies lacrymales
WO2015111553A1 (fr) * 2014-01-22 2015-07-30 株式会社カネカ Tube lacrymal
US20190336339A1 (en) * 2016-01-27 2019-11-07 Sinopsys Surgical, Inc. Paranasal sinus access implant devices and related products and methods

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